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- Access the Portal: Visit the CDSCO online portal, known as SUGAM, at SUGAM Portal.
- Product Description: Detailed description including the device’s intended use, design, and specifications.
- Compile Documentation: Gather all necessary documents and materials as outlined below.
- CDSCO Online Portal: Submit your application through the CDSCO online portal known as SUGAM. This portal is used for the electronic submission of applications and tracking their status.
- 2024-08-27Class A Devices: The registration fee is relatively lower compared to higher-class devices. Typically, it ranges from ₹10,000 to ₹25,000, depending on the type and quantity of devices.
- 2024-08-27Company Registration: Ensure that your company is legally registered and compliant with Indian laws.
- 2024-08-27Document Collection: Compile required documents such as product specifications, labeling, proof of compliance with quality standards (like ISO 13485), and clinical evidence if applicable.
- Prepare Documentation: Gather required documents including a product description, labeling information, and proof of compliance with ISO standards or equivalent.
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Email address：hito.lin@grzan.cn
Add: Room 103-108, Building B, Block 2, Bangkai Science and Industrial Park, NO.9, Guangyuan 5th Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Province, China.
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